WO2018180566A1

WO2018180566A1 - Needle-equipped outer cylinder and method for manufacturing same

Info

Publication number: WO2018180566A1
Application number: PCT/JP2018/010345
Authority: WO
Inventors: 昌史竹本; 二三也松本
Original assignee: テルモ株式会社
Priority date: 2017-03-31
Filing date: 2018-03-15
Publication date: 2018-10-04
Also published as: CN110475575A; US20200023133A1; US11590287B2; EP3603708A4; EP3603708A1; JPWO2018180566A1

Abstract

This needle-equipped outer cylinder 1 comprises: a needle pipe 3; a joint member 4 having a needle pipe containing hole 42 for containing the base end-side portion of the needle pipe, the joint member 4 also having a joint outer peripheral section 47 having a reduced outer diameter; and an outer cylinder member 2 provided with a front end joint section 22 having an inner cavity 26 capable of receiving the joint member 4 from the front end side. The outer cylinder member is provided with a protrusion 28 provided at the base end of the inner cavity 26. The joint member is provided with a contact section 48 in contact with the protrusion of the outer cylinder member. The joint member 4 is inserted in the inner cavity in the outer cylinder member, and the protrusion 28 of the outer cylinder member and the contact section of the joint member 4 are in contact with each other. The joint member 4 is joined and secured to the outer cylinder member and the needle pipe by a thermal weld section 45 formed at a position located a predetermined distance toward the base end from the front end of the front end joint section.

Description

Outer cylinder with needle and method for manufacturing the same

The present invention relates to an outer cylinder with a needle in which a needle tube of a syringe is directly fixedly joined to the tip of the outer cylinder of the syringe, a manufacturing method thereof, and a prefilled syringe using the outer cylinder with a needle.

In a small-capacity syringe used for insulin administration or vaccine administration, an external cylinder with a needle in which the needle tube of the syringe is directly fixed and joined to the tip of the external syringe cylinder in advance may be used. In addition to a method of joining the needle tube to the tip of the outer tube with an adhesive or the like, a method of joining the needle tube to the tip of the outer tube by insert molding, A method of thermally welding to a cylinder is known (see Patent Document 1). Further, a method is known in which a cylindrical joining member is interposed between a needle tube and an outer cylinder, and the three members are assembled by press-fitting the joining member into the outer cylinder (see Patent Document 2). .

JP 2005-342100 A JP 2004-154210 A International Publication WO2014 / 136239 (US Publication No. 2015-374931, EP Publication No. 2965774)

As in

Patent Documents

1 and 2, when using a joining member, as a method of thermally welding the joining member and the outer cylinder, a joining member having a tapered portion whose outer diameter decreases from the distal end side toward the proximal end side, Using the outer cylinder having a distal end joint portion having a tapered lumen capable of receiving the taper portion of the joining member, the taper portion and the tapered shape are pressed against the outer cylinder in the proximal direction. It is preferable to heat weld the lumen. And in this heat welding process, it is not necessary to heat weld all the contact surfaces of a joining member and an outer cylinder, and what is necessary is just to form the part heat-welded cyclically | annularly. Therefore, a part of the outer cylinder that comes into contact with the joining member has a non-thermally welded portion that is not heated to the softening point or higher and is not thermally welded to the joining member.

Further, in the heat welding step, when the entire joining member is heated to a certain level or more, the distal end side portion of the joining member which is not inserted into the tapered lumen of the outer cylinder is softened, and the tapered lumen is provided. There is a risk of deformation to an outer diameter larger than the inner diameter of the opening. When such deformation occurs, the deformed portion cannot enter the tapered lumen. For this reason, it is difficult to perform heat welding while pressing the surfaces of the tapered portion and the tapered lumen, and it is difficult to improve the reliability of welding between the joining member and the outer cylinder.

For this reason, the heating range is limited so that heat welding can be surely performed in a portion excluding the portion near the tip, such as an intermediate portion of the joining member, while the tip side portion of the joining member is not softened. It is desirable. Under such circumstances, the outer cylinder of the portion that comes into contact with the joining member has a portion that comes into contact with the non-thermally welded portion. And after manufacture of the outer cylinder with a needle | hook, there existed a problem that a crack generate | occur | produced in the part which is a contact part and is a non-thermal welding part.

Therefore, the applicant of the present application has proposed Patent Document 3.
The outer cylinder 1 with a needle of Patent Document 3 penetrates from the distal end side to the proximal end side with the needle tube 3 and the needle insertion hole 42 through which the needle tube 3 is inserted from the distal end to the proximal end. It consists of the joining member 4 having the tapered portion 47 and the outer cylinder member 2 including the tip joining portion 22 having the tapered lumen 26 capable of receiving the tapered portion 47 of the joining member 4. The joining member 4 is inserted into the lumen 26 of the distal end joining portion 22 of the outer cylinder member 2 and the distal end of the joining member 4 is formed by a thermal welding portion 45 formed at a position that is a predetermined length proximal side from the distal end of the distal end joining portion 22. It is fixed to the joint 22. The tip joining portion 22 has a non-welding contact portion 46 that is a non-thermal welding portion and comes into contact with the joining member 4 at a portion closer to the tip than the heat welding portion 45. The non-welding contact portion 46 has residual strain and does not have a crack.

The thing of patent document 3 has a sufficient effect.
However, there may be a difference in molding between the outer cylinder member 2 and the joining member 4 that are molded products. When this occurs in the tapered portion of the joining member and the tapered lumen of the tip joining portion of the outer cylinder, When the joining member is inserted into the tip joint portion of the cylindrical member, the joining member is not sufficiently fixed in the tip joint portion, and there is a possibility that the joining between the joining member and the outer cylinder by heat welding is not stable.

The present invention has been made in view of the above points, and has a needle tube, a needle tube storage hole that penetrates from the distal end to the proximal end and into which the needle tube is inserted, and an outer diameter that decreases from the distal end side toward the proximal end side. An outer cylinder with a needle comprising a joining member having a taper portion that has a diameter, and an outer cylinder member having a distal end joining portion having a lumen capable of receiving the taper portion of the joining member, wherein the joining member is an outer cylinder member It is an object of the present invention to provide an outer cylinder with a needle that is well fixed and bonded, a method for producing the same, and a prefilled syringe using the outer cylinder with a needle.

What achieves the above object is as follows.
A joining member having a needle tube, a needle tube housing hole for housing a proximal end portion of the needle tube, and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube housing hole; and the joining outer peripheral portion of the joining member from the distal end side. An outer cylinder with a needle comprising an outer cylinder member having a distal end joint having a receivable lumen,
The needle tube storage hole passes through the joining member from the distal end of the joining member to the proximal end of the joining member,
The outer cylinder member is provided at a proximal end portion of the lumen and includes a protruding portion projecting into the lumen, and the joining member projects at the proximal end portion of the joining member. An abutting portion that abuts on a portion, at least the joining outer peripheral portion of the joining member is inserted into the lumen of the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is Abutting against the protrusion of the outer cylinder member;
The joining outer peripheral portion of the joining member has a heat-welded portion formed at a position that is a predetermined long base end side from the distal end of the distal joint portion of the outer cylinder member, and the joining outer peripheral portion of the joining member is An outer cylinder with a needle fixedly bonded to the inner peripheral surface of the tip bonded portion at the outer peripheral portion of the heat welded portion and fixedly bonded to the outer peripheral surface of the needle tube at the inner peripheral portion of the heat welded portion.

Moreover, what achieves the said objective is as follows.
A joint member having a needle tube, a needle tube storage hole into which the needle tube is inserted, and a joint outer peripheral portion provided in an outer peripheral portion of the needle tube storage hole; and a lumen capable of receiving the joint outer peripheral portion of the joint member A method for manufacturing an outer cylinder with a needle comprising an outer cylinder member provided with a tip joint portion,
The outer cylinder member provided with a protruding portion protruding into the lumen at a proximal end portion of the lumen, and the joining member provided with a contact portion contacting the protruding portion of the outer cylinder member at a proximal end portion; A preparation step of preparing the needle tube;
The needle tube is inserted into or inserted into the needle tube housing hole of the joining member, the joining member is inserted into the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is the outer cylinder member An assembly step of assembling the needle tube, the joining member, and the outer cylinder member so as to abut against the protruding portion of
While the distal end portion of the joining member is pressed in the proximal direction of the joining member by the pressing member, the needle tube is heated by a heating device that heats the needle tube, whereby the joining outer peripheral portion of the joining member is moved to the outer cylinder. A method of manufacturing an outer cylinder with a needle, comprising: a welding step of thermally welding the inner peripheral surface of the tip joint portion of the member and the outer peripheral surface of the needle tube.

FIG. 1 is a front view of an outer cylinder with a needle of the present invention. 2 is a cross-sectional view of the outer cylinder with needle of FIG. 1 taken along the line AA. 3 is a plan view of the needled outer cylinder of FIG. FIG. 4 is an enlarged longitudinal sectional view of the distal end portion of the outer cylinder with a needle of the present invention. FIG. 5 is a longitudinal sectional view of an outer cylinder member used in the outer cylinder with a needle of the present invention. FIG. 6 is an enlarged front view of a joining member used in the outer cylinder with a needle of the present invention. FIG. 7 is a plan view of the joining member of FIG. FIG. 8 is a longitudinal sectional view of the joining member of FIG. FIG. 9 is an exploded perspective view of the outer cylinder with a needle of the present invention. FIG. 10 is a front view of a prefilled syringe using the outer cylinder with a needle of the present invention. 11 is a longitudinal sectional view of the prefilled syringe of FIG. FIG. 12 is an explanatory diagram for explaining a preheating step in the method of manufacturing an outer cylinder with a needle according to the present invention. FIG. 13 is an explanatory diagram for explaining a joining member welding step in the method of manufacturing an outer cylinder with a needle of the present invention. FIG. 14 is an explanatory diagram for explaining a preheating step in the method of manufacturing a needle-equipped outer cylinder according to another embodiment of the present invention. FIG. 15 is an enlarged longitudinal sectional view of a tip portion of a needle-equipped outer cylinder according to another embodiment of the present invention. FIG. 16 is an enlarged longitudinal sectional view of a tip portion of a needle-equipped outer cylinder according to another embodiment of the present invention. 17 is an enlarged cross-sectional view of the distal end portion of the outer cylinder member shown in FIG.

Hereinafter, the needle-equipped outer cylinder of the present invention will be described using the embodiments shown in the drawings.

The outer cylinder 1 with a needle of the present invention is provided in the outer periphery of the needle tube 3, the needle tube storage hole 42 for storing the proximal end portion of the needle tube 3, and the needle tube storage hole 42 (in other words, arranged around the axis). ) The joint member 4 having the joint outer peripheral portion 47 and the outer cylinder member 2 including the tip joint portion 22 having the lumen 26 capable of receiving the joint outer peripheral portion of the joint member 4 from the front end side. The needle tube storage hole 42 passes through the joining member 4 from the distal end of the joining member 4 to the proximal end of the joining member 4.

The outer cylinder member 2 is provided at a proximal end portion of the lumen 26 and includes a projecting portion 28 protruding into the lumen 26, and the joining member 4 projects from the proximal end portion of the joining member 4. A contact portion 48 that contacts the portion 28 is provided. At least the joining outer peripheral portion 47 of the joining member 4 is inserted into the lumen 26 of the tip joining portion 22 of the outer cylinder member 2, and the contact portion 48 of the joining member 4 is in contact with the protruding portion 28 of the outer cylinder member 2. It touches.

The joining outer peripheral portion 47 of the joining member 4 has a heat-welded portion 45 formed at a position that is a predetermined long base end side from the tip of the tip joining portion 22 of the outer cylinder member 2, and the joining outer peripheral portion 47 of the joining member 4. Are fixedly bonded to the inner peripheral surface of the tip bonded portion 22 at the outer peripheral portion of the heat welded portion 45, and fixedly bonded to the outer peripheral surface of the needle tube 3 at the inner peripheral portion of the heat welded portion 45.

The needle-equipped outer cylinder of the present invention is used to puncture the needle tip from the surface of the skin and inject a drug solution into a living body.
As shown in FIGS. 1 to 4, the outer cylinder 1 with a needle of this embodiment includes a needle tube 3, a joining member 4 to which the needle tube 3 is fixedly joined, and an outer cylinder member 2 to which the joining member 4 is firmly joined. And. Further, a cap 6 is attached to the outer cylinder 1 with a needle as shown in FIGS.

As shown in FIG. 1, FIG. 3 and FIG. 9, the needle tube 3 is 27 to 30 G (outer diameter: φ0.41˜) based on the ISO medical needle tube standard (ISO9626: 1991 / Amd.1: 2001 (E)). 0.31 mm) is used. The needle tube 3 having a size of 26G or more may be used.

A needle tip 32 that is punctured by a living body is formed at one end of the needle tube 3 in the axial direction. The needle tip 32 is formed at an acute angle with a blade surface. The needle tube 3 has a needle tip 32 projecting from a distal end side cylindrical portion (tip portion) 43 described later of the joining member 4, and a proximal end 33 of the needle tube 3 on the opposite side of the needle tip 32 is a joining outer peripheral portion described later of the joining member 4. 47 (in this embodiment, a taper portion) is configured to protrude from 47 and be disposed in a distal end joining portion 22 (described later) of the outer cylindrical member 2.
The intermediate part 31 of the needle tube 3 is inserted into a later-described needle tube storage hole 42 of the joining member 4. At least the surface of the intermediate portion 31 in the needle tube 3 is a rough surface by blasting or the like. As a result, when the needle tube 3 and the joining member 4 are joined by heat welding, the softened resin enters the irregularities of the rough surface of the needle tube 3, thereby increasing the joining strength between the needle tube 3 and the joining member 4. Can do. Moreover, liquid-tightness can be improved because the softened resin enters into the unevenness of the rough surface of the needle tube 3.

As the material of the needle tube 3, for example, stainless steel is preferable. However, the present invention is not limited to this, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. Further, the needle tube 3 can be not only a straight needle but also a tapered needle having at least a part tapered. The cross-sectional shape of the needle tube 3 is not limited to a circle but may be a polygon such as a triangle. A coating agent made of, for example, a silicone resin or a fluorine resin may be applied to the surface of the needle tube 3 on the needle tip 32 side.

Next, the joining member 4 will be described.
As shown in FIGS. 6 to 8, the joining member 4 has a distal end side cylinder part (distal end part) 43 and a proximal end side that is smaller in outer diameter than the distal end side cylinder part 43 and longer than the distal end side cylinder part 43. It is comprised from the cylinder part 41. FIG. The joining member 4 includes a needle tube storage hole 42 into which the needle tube 3 is inserted and a joining outer peripheral portion 47 formed on the outer peripheral portion thereof. The distal end side cylinder portion 43 is formed in a cylindrical shape having a substantially uniform outer diameter. In this embodiment, the outer surface of the base end side cylinder portion 41, in other words, the outer surface of the joining outer peripheral portion 47 is formed in a tapered shape whose outer diameter continuously decreases toward the base end side of the joining member 4. ing. Moreover, the radial cross section of the joining outer peripheral part 47 is formed circularly. In particular, in the present embodiment, it is formed in a substantially circular shape.

And the joining member 4 is provided with the contact part 48 contact | abutted with the protrusion part 28 provided in the base end part of the inner cavity 26 of the outer cylinder member 2, so that it may mention later. In this embodiment, the contact portion 48 of the joining member 4 is configured by an annular rib that protrudes rearward from the base end (specifically, the base end face) of the joining member 4. Note that the contact portion may be one or a plurality of ribs that are not annular. Furthermore, the abutting portion may be constituted by the base end face of the joining member 4 instead of providing the rib as described above. Further, the contact portion may be formed by a protrusion, an annular recess, or the like provided on the proximal end side portion of the joining member 4.

The joining member 4 has a needle tube storage hole 42 into which the needle tube 3 is inserted. The needle tube storage hole 42 has a needle tube storage portion 42a that stores the proximal end portion of the needle tube, and a communication hole 42b that communicates with the needle tube storage portion 42a and is surrounded by a needle tube locking portion 49 described later. The diameter of the needle tube storage portion 42a of the needle tube storage hole 42 is set to be about 0.02 to 0.14 mm larger than the outer diameter of the needle tube 3, and preferably about 0.05 to 0.11 mm. When the 27 to 30 G needle tube 3 described above is used, the gap between the needle tube 3 and the needle tube 3 can be set as described above by setting the diameter of the needle tube storage portion 42a to 0.43 to 0.45 mm. By determining as described above, the joining strength of the needle tube 3 after joining can be ensured, and the needle tube 3 after joining can be prevented from tilting beyond a predetermined level. In addition, when using a 26G or more needle tube, the internal diameter of the needle tube storage part 42a is set to 0.46 mm or more.

The thickness from the outer surface of the joining member 4 to the needle tube storage hole 42 is set to 0.38 to 0.48 mm. By using such a joining member 4, the joining strength of the needle tube 3 is ensured, and the joined needle tube 3 and the needle tube 3 of 27 to 30G are prevented from tilting to a predetermined level or more. The outer cylinder 1 with a needle | hook can be manufactured using each of these.

Further, as shown in FIG. 8, the distal end side portion (inside the distal end side cylindrical portion 43) of the needle tube storage hole 42 is an enlarged diameter portion 44 whose diameter is larger than that of other portions. Furthermore, an annular rib 55 that protrudes gently is formed at the proximal end of the enlarged diameter portion 44. The front and back of the apex of the annular rib 55 are gentle inclined surfaces. An annular recess 56 is provided on the base end side of the annular rib 55.

And in the outer cylinder 1 with a needle | hook of this Example, as shown in FIG.4, FIG.8, the joining member 4 is provided with the needle tube latching | locking part 49 provided in the base end part of the needle tube accommodation hole 42. FIG. As shown in FIG. 4, the proximal end 33 of the needle tube 3 inserted into the joining member 4 abuts on the needle tube engaging portion 49, and movement in the proximal direction, in other words, removal from the joining member 4 is restricted. The For this reason, the protruding length of the needle tube 3 from the tip of the joining member 4 is constant.

In this embodiment, the needle tube locking portion 49 is formed by an annular protruding portion that protrudes from the inner surface of the needle tube storage portion 42 a of the needle tube storage hole 42 of the joining member 4. Moreover, as an annular protrusion part, what has a standing surface which goes to a front-end | tip direction with respect to the inner surface of the needle tube accommodating part 42a is preferable. By setting it as such, the contact state with the base end 33 of the needle tube 3 is stabilized. However, the needle tube locking portion 49 may include, for example, an inclined surface that decreases in diameter toward the proximal end. The needle tube locking portion 49 may be one or a plurality of ribs that are not annular. In this embodiment, the needle tube locking portion 49 is provided at the proximal end of the needle tube storage hole 42. However, the needle tube locking portion 49 may be located not on the proximal end of the needle tube storage hole 42 but on the distal end side of a predetermined length from the proximal end.

The needle tube storage hole 42 is surrounded by the needle tube locking portion 49 and has a communication hole 42b having a smaller diameter than the needle tube storage portion 42a. The inside of the outer cylinder main body 21 of the outer cylinder member 2 and the needle tube 3 communicate with each other through the communication hole 42b. The diameter of the communication hole 42b is preferably larger than the inner diameter of the needle tube and smaller than the outer diameter of the needle tube. Thereby, when the chemical | medical solution with which the inside of the outer cylinder main body 21 was discharged | emitted from the needle tube 3, a chemical | medical solution can pass smoothly through the communicating hole 42b.

As a material for forming the joining member 4 and the outer cylinder member 2 described later, for example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile- Examples thereof include various resins such as butadiene-styrene copolymer, polyester such as polyethylene terephthalate, butadiene-styrene copolymer, and polyamide (for example, nylon 6,

nylon

6,6,

nylon

6,10, nylon 12). Among these, it is preferable to use a resin such as polypropylene, cyclic polyolefin, polyester, or poly- (4-methylpentene-1). It is preferable that the forming material of the joining member 4 and the outer cylinder member 2 is substantially transparent in order to ensure internal visibility.

Next, the outer cylinder member 2 will be described.
As shown in FIG. 5, the outer cylinder member 2 includes an outer cylinder main body 21 that is filled with a chemical solution, and a tip joint portion 22 to which the joining member 4 is firmly joined. The outer cylinder main body 21 is formed in a substantially cylindrical shape having an internal storage portion. A flange 23 is formed on the base end side of the outer cylinder main body 21 in the axial direction. That is, the outer cylinder member 2 is a syringe outer cylinder member that can be filled with a chemical solution.

The distal end joining portion 22 includes a joining member receiving portion 24 that is continuous with the outer cylinder main body 21 and a distal-end-side enlarged portion 25 that is continuous with the joining member receiving portion 24. The outer shape of the joining member receiving portion 24 is formed in a cross shape in the radial direction, that is, four ribs extending in the axial direction. In the bonding member receiving portion 24, a lumen 26 for receiving the bonding outer peripheral portion 47 of the bonding member 4 from the distal end side is formed.

And the protrusion part 28 provided in the base end part of the lumen | bore 26 is provided. In this embodiment, the protrusion 28 is an annular protrusion that protrudes from the inner surface of the lumen 26. Moreover, as an annular protrusion part, what has an upright surface which goes to a front-end | tip direction with respect to the inner surface of the internal cavity 26 with which the outer cylinder member 2 shown in FIG.4, FIG.5 and FIG.17 is provided is preferable. By setting it as such, the contact state with the contact part (base end surface) of the joining member 4 is stabilized. However, as a protrusion part, you may provide the inclined surface which diameter-reduces toward a base end direction, for example. A through hole is formed in the protruding portion 28. Note that the protruding portion may be one or a plurality of ribs that are not annular. In this embodiment, the protrusion 28 is provided at the lower end of the lumen 26. However, the protruding portion 28 may be located on the distal end side of the predetermined length from the lower end instead of the lower end of the lumen 26. The protrusion height from the inner surface of the inner cavity 26 of the protrusion 28 (the inner surface near the protrusion) is preferably 0.03 to 0.35 mm, and more preferably 0.05 to 0.25 mm. Note that the protruding end of the protruding portion 28 is located on the inner peripheral side with respect to the outer peripheral surface of the base end portion of the joining member, and is positioned on the outer peripheral side with respect to the inner peripheral surface (communication hole 42b) of the needle tube locking portion 49. It is preferable to do. Thereby, when the chemical liquid filled in the outer cylinder main body 21 is discharged from the needle tube 3, the chemical liquid can smoothly pass through the inside of the protruding portion 28.

And in the outer cylinder 1 with a needle | hook of this Example, the joining outer peripheral part (taper part) 47 of the joining member 4 is formed substantially the same as the taper form of the tapered lumen 26 of the front-end | tip junction part 22 of the outer cylinder member 2. FIG. Has been. Therefore, when the joining outer peripheral portion 47 of the joining member 4 is inserted into the lumen 26 of the outer cylinder member 2, the contact portion 48 (specifically, the projecting portion 28 of the lumen 26 of the outer cylinder member 2 is provided. Specifically, in a state in which the base end surface is in contact, the joint outer peripheral portion 47 is formed in a shape that can contact the tapered lumen 26 on almost the entire surface. The radial cross section of the tapered lumen 26 is formed in a circular shape. In particular, the outer cylinder of this embodiment is formed in a substantially circular shape. Further, the thickness of the portion of the joining member receiving portion 24 where there is no external rib is preferably 0.5 to 2.0 mm, and more preferably 0.7 to 1.3 mm.

And, the tapered form of the tapered lumen 26 and the joint outer peripheral portion 47 are substantially the same. Further, in the distal end side enlarged diameter portion 25, a distal end side cylindrical portion storage portion 27 that communicates with the tapered lumen 26 and stores the distal end side cylindrical portion 43 of the joining member 4 is formed. The distal end side cylinder portion storage portion 27 is formed to have a larger diameter than the distal end of the tapered lumen 26. The taper angles of the tapered lumen 26 and the joining outer peripheral portion 47 of the joining member 4 are not particularly limited, but are preferably 1 to 3 degrees. As shown in FIG. 4, the inner diameter of the distal end side cylindrical portion storage portion 27 is substantially the same as or slightly larger than the outer diameter of the distal end side cylindrical portion 43 of the joining member 4, and accommodates the distal end side cylindrical portion 43. It is provided as possible.

Moreover, in the outer cylinder 1 with a needle | hook of this Example, as shown in FIG. 4, FIG. 8, as mentioned above, the joining member 4 is provided with the needle tube latching | locking part 49 provided in the base end part of the needle tube accommodation hole 42. FIG. ing. However, like the outer cylinder 1a with a needle shown in FIG. 15, the outer cylinder member 2a may include a needle tube locking portion 29. In the outer cylinder 1a of this embodiment, the joining member 4a does not have a needle tube locking portion. And the opening diameter of the proximal end opening of the joining member 4a is larger than the outer diameter of the proximal end 33 of the needle tube 3, and the needle tube 3 inserted into the joining member 4a penetrates the joining member 4a, The base end 33 protrudes from the base end opening of the joining member 4a. A needle tube locking portion 29 is provided at the proximal end of the lumen 26 of the outer cylinder member 2a, and the protruding proximal end 33 of the needle tube 3 abuts on the needle tube locking portion 29, and a further base portion is provided. Movement in the end direction is restricted. For this reason, the protruding length of the needle tube 3 from the tip of the outer cylinder member 2a is constant.

In this embodiment, the needle tube locking portion 29 is formed by an annular protruding portion that protrudes from the inner surface of the proximal end portion of the lumen 26 of the outer cylinder member 2a. Further, as the annular projecting portion, it is preferable to have an upstanding surface in the distal direction relative to the inner surface of the lumen 26. By setting it as such, the contact state with the base end 33 of the needle tube 3 is stabilized. However, the needle tube locking portion 29 may include, for example, an inclined surface that decreases in diameter toward the proximal end. The needle tube locking portion 29 may be one or a plurality of ribs that are not annular. In this embodiment, the needle tube locking portion 29 is provided at the proximal end of the lumen 26. However, the needle tube locking portion 29 may be located not on the proximal end of the lumen 26 but on the distal end side with respect to a predetermined length from the proximal end.

Further, like the outer cylinder 1b with a needle shown in FIG. 16, the protruding portion 28a provided at the proximal end portion of the lumen 26 of the outer cylinder member 2b is a contact portion of the proximal end portion of the joining member 4a. 48 may be in contact with the proximal end 33 of the needle tube 3. In this case, the protrusion 28a has a higher protrusion height than the protrusion 28 of the outer cylinder 1a described above.

In the present embodiment, an example in which the shape of the outer cylinder main body 21 is formed in a substantially cylindrical shape has been described. However, the shape of the outer cylinder main body 21 may be a hollow quadrangular prism shape or a hexagonal prism shape.
As the material of the outer cylinder member 2, it is preferable to select a material having compatibility with the forming material of the joining member 4 to be used.

In particular, as will be described later, the distal end joining portion 22 of the outer cylinder member 2 and the joining member 4 are fixedly joined by thermal welding. For this reason, it is preferable that the material of the outer cylinder member 2 and the material of the joining member 4 are substantially the same material. Thereby, the favorable joining property of the front-end | tip junction part 22 and the joining member 4 can be obtained, and the front-end | tip junction part 22 and the joining member 4 can be fixed firmly. Moreover, since the welding part of the front-end | tip junction part 22 and the joining member 4 can be made not conspicuous, the beauty | look of the outer cylinder 1 with a needle | hook can be improved.

The needle tube 3, the joining member 4 and the outer cylinder member 2 are welded by a manufacturing method which will be described later, and constitutes an outer cylinder 1 with a needle as shown in FIGS. As shown in FIG. 4, the needle-equipped outer cylinder 1 has a heat-welded portion 45 formed at a position that is a predetermined length proximal side from the distal end of the distal end joint portion 22 of the outer cylindrical member 2. At a position on the base end side of the predetermined length from the distal end of the distal end joint portion 22 of the outer cylinder member 2, the welded outer peripheral portion of the joining member 4 is melted and solidified, whereby a heat welded portion 45 is formed. The joining member 4 is joined to the inner peripheral surface of the tip joint portion 22 of the outer cylinder member 2 at the outer peripheral portion of the thermal welding portion 45, and the outer peripheral surface of the needle tube 3 at the inner peripheral portion of the thermal welding portion 45. It is firmly joined. And in the outer cylinder of this invention, it does not contain a bubble in the heat welding part 45 and its vicinity. For this reason, there is no weak part resulting from a bubble.

Further, the tip joining portion 22 has a non-welding contact portion 46 that is not thermally welded to the joining member 4 and is in contact with the joining member 4 in a portion on the tip side from the heat welding portion 45. Yes. In this way, the tip joint portion 22 has the non-welding contact portion 46, as will be described later, so that the portion near the tip of the joint member 4 is softened and is not deformed so as to be deformed. This is because only the close part is heated and welded.

And, the non-welding contact portion 46 in the outer cylinder is preferably one having residual strain and no crack. And it has the non-welding contact part 46 which was not heat-welded with the joining member 4, and contacted the joining member 4, and the non-welding contact part 46 has a residual distortion and does not have a crack. A thing can be manufactured with the manufacturing method of the outer cylinder with a needle | hook mentioned later.

Further, the non-welding contact portion 46 has a phase difference in birefringence measurement due to residual strain, and the occurrence frequency of the phase difference exceeding 800 nm in the birefringence measurement is 1 of the occurrence frequency of the phase difference less than 800 nm. / 10 or less is preferable. In other words, it is preferable that the area where the phase difference in the predetermined area portion of the vertical section of the outer cylinder in the non-welding contact portion 46 is 800 nm or more is 10% or less.

Here, as the “phase difference”, an in-plane birefringence phase difference per unit thickness with respect to incident light from the radial direction of the tip joint portion 22 at the non-welding contact portion 46 is used. The phase difference uses two types of characteristic data: retardation (birefringence phase difference) characteristic Re data measured by a two-dimensional birefringence measuring apparatus, and surface distribution data of an axis (fast axis, slow axis) angle. Is required. The phase difference (in-plane phase difference) can be measured using a commercially available phase difference measuring device (for example, “WPA-100 manufactured by Photonic Lattice,“ KOBRA-21ADH ”manufactured by Oji Scientific Instruments) or the Senalmon method.

If the frequency of occurrence of the phase difference exceeding 800 nm in the birefringence measurement is 1/10 or less of the frequency of occurrence of the phase difference of less than 800 nm, the non-welding contact portion 46 is a portion that has a resident strain but is greatly distorted. (For example, the part which becomes a factor of a crack and subsequent crack generation | occurrence | production) does not have.

In particular, it is preferable that the non-welding contact portion 46 has no phase difference exceeding 900 nm in birefringence measurement. In other words, it is preferable that the area where the phase difference in the predetermined area portion of the cross section in the vertical direction of the outer cylinder in the non-welding contact portion 46 is substantially zero is zero. Further, the non-welding contact portion 46 preferably has a phase difference occurrence frequency peak in the birefringence measurement within a range of 100 nm to 500 nm.

Next, the prefilled syringe 10 using the outer cylinder 1 with a needle | hook of this invention is demonstrated.
The prefilled syringe 10 of the present invention is housed in the outer cylinder body 21 and the outer cylinder body 21 of the outer cylinder 1, the chemical liquid 12 filled in the outer cylinder body 21 of the outer cylinder 1, and the outer cylinder body 21. And a cap 6 that is attached to the tip of the outer cylinder 1 with a needle and seals the needle tip 33 of the needle tube 3.

As shown in FIG. 10, the syringe 10 includes the outer cylinder 1 with a needle described above, a cap 6 that is attached to the distal end portion of the outer cylinder 1 with a needle and seals the needle tip 32 of the needle tube 3, and an outer cylinder with a needle. 1 is provided with a gasket 5 that is accommodated in the outer cylinder main body 21 and is slidable in the outer cylinder main body 21, and a plunger 7 attached to the gasket 5. The plunger 7 includes a main body portion 71, a gasket mounting portion 72 formed at the distal end of the main body portion 71, and a pressing portion 73 provided at the base end portion. The gasket also includes a plunger mounting portion that receives and engages the gasket mounting portion 72 of the plunger 7. The syringe 10 of this embodiment is a prefilled syringe in which the chemical liquid 12 is filled in the outer cylinder main body 21 of the outer cylinder 1 with a needle.

The cap 6 is formed in a cylindrical shape, the axial base 61 side is open, and the axial tip is closed. The cap 6 is formed from an elastic member such as rubber or elastomer, for example. The heel cap 6 is attached to the distal end joint portion 22 of the outer cylinder member 2 so as to cover the needle tip 32 of the needle tube 3 and the distal end joint portion 22 of the outer cylinder member 2. Then, as shown in FIG. 11, the needle tube 3 side and the distal end joint portion 22 are inserted into the lumen portion 62 of the cap 6. Further, in this embodiment, the cap 6 is provided with a cylindrical envelope member 8 that is mounted on the outside of the cap 6 and engaged with the cap 6.

Note that the inner diameter of the lumen portion 62 of the cap 6 is formed to be substantially equal to the outer diameter of the distal end side fitting portion (front end side enlarged diameter portion) 25 of the distal end joint portion 22 or from the distal end side fitting portion 25. Is slightly smaller. Therefore, when the cap 6 is attached to the distal end joining portion 22, the outer peripheral surface of the distal end side fitting portion 25 is in close contact with the inner peripheral surface of the cap 6. Therefore, the space covering the needle tube 3 protruding from the joining member 4 is sealed by the distal end side fitting portion 25 and the inner peripheral surface of the cap 6. By comprising in this way, it can prevent that microbe adheres to the needle point 32. FIG. At the same time, the needle tip holding part 63 holds the needle tip 32.

The inner peripheral surface of the cap 6 tightens a constricted portion at the boundary between the distal end side fitting portion (front end side enlarged diameter portion) 25 and the tapered fitting portion (joining member receiving portion) 24 in the distal end joint portion 22 by its elastic force. . Thus, the inner peripheral surface of the cap 6 and the constricted portion of the tip joint portion 22 are engaged, and the cap 6 can be prevented from being detached from the tip joint portion 22 during transport.

Next, the manufacturing method of the outer cylinder 1 with a needle | hook is demonstrated.
The method for manufacturing an outer cylinder with a needle according to the present invention includes a needle tube 3, a needle tube storage hole 42 that penetrates from the distal end to the proximal end and accommodates the proximal end side portion of the needle tube 3, and an outer side from the distal end side toward the proximal end side. The joining member 4 has a joining outer peripheral portion 47 whose diameter is reduced, and the outer cylinder member 2 having a distal end joining portion 22 having a lumen 26 capable of receiving the joining outer peripheral portion 47 of the joining member 4 from the distal end side. It is a manufacturing method of an outer cylinder.

In the manufacturing method of the outer cylinder with a needle according to the present invention, the outer cylinder member 2 is provided with a protruding portion 28 provided at the proximal end portion of the lumen 26, and the protruding portion of the outer cylinder member 2 is used as the joining member 4. What has the contact part 48 which contacts 28 is used.
And in the manufacturing method of the outer cylinder with a needle | hook of this invention, the needle tube 3 is inserted in the needle tube accommodation hole 42 of the joining member 4, or it inserts and fixes, the joining member 4 is inserted in the front-end | tip junction part 22 of the outer cylinder member 2, and An assembly process for bringing the protruding portion 28 of the outer cylinder member 2 into contact with the contact portion 48 of the joining member 4 and pressing the distal end portion of the joining member 4 in the proximal direction of the joining member 4 by the pressing member. The joining member welding step of thermally welding the joining member 4 to the tip joining portion 22 of the outer cylinder member 2 is performed.

In order to manufacture the outer cylinder 1 with a needle of the present invention, a needle tube 3, a joining member 4 and an outer cylinder member 2 are prepared as shown in FIG. The needle tube 3 is formed as a desired tubular body by, for example, flat metal pressing or hollow pipe swaging. The joining member 4 and the outer cylinder member 2 are formed by injection molding. In this way, by molding the joining member 4 and the outer cylinder member 2 separately, the mold can be reduced in size and simplified.

Next, the assembly process to the outer cylinder member of the needle tube 3 and the joining member 4 is performed.
In this assembly process, the joining member 4 is inserted into the tapered lumen 26 of the distal end joining portion 22 in the outer cylinder member 2. When the joining member 4 is pushed to the proximal end in the distal end joining portion 22, the protruding portion 28 of the outer cylinder member 2 and the abutting portion 48 of the joining member 4 are in contact with each other. In this embodiment, since the lumen 26 in the distal end joint portion 22 of the outer cylinder member 2 is a tapered lumen 26, the proximal end side cylinder portion 41 and the joint outer peripheral portion (taper) of the joint member 4 are used. Part) 47 is in a state of being taper-fitted to the tapered lumen 26 of the tip joint part 22 or a state close to taper-fitting.

Next, the needle tube 3 is inserted. In this insertion step, the needle tube 3 is inserted into the needle tube storage hole 42 of the joining member 4 from the proximal end side, and the needle tube 3 is assembled to the joining member 4 attached to the outer cylinder member 2. In addition, the needle tube 3 is not inserted into the joining member 4 after the joining member 4 is attached to the outer cylinder member 2, but before the attachment of the joining member 4 to the outer cylinder member 2, the needle tube 3 is attached to the joining member 4 in advance. May be inserted and fixed. Moreover, you may use what formed the needle tube 3 and the joining member 4 previously integrally by insert molding.

In this embodiment, as shown in FIGS. 4 and 12, the joining member 4 is provided with a needle tube locking portion 49 provided at the proximal end portion of the needle tube storage hole 42. For this reason, the proximal end 33 of the needle tube 3 inserted into the joining member 4 abuts on the needle tube engaging portion 49, and movement in the proximal direction, in other words, removal from the joining member 4 is restricted.

And it is after an assembly process as mentioned above, and it is preferable to perform a preheating process before the joining member welding process mentioned later.
In the preheating step, it is preferable to heat to a temperature not higher than the softening point of the forming material of the outer cylinder member 2. In particular, it is preferable to heat to a temperature not lower than the glass transition point of the forming material of the outer cylinder member 2 and not higher than the softening point. Specifically, when the outer cylinder member 2 made of cyclic polyolefin (COP) is used, the needle-equipped outer cylinder 1 after the insertion step described above is set to be within a heating range of 110 ° C. to 150 ° C. It is preferable to heat.

As the heating means, as shown in FIG. 12, it is preferable to use two halogen heaters 11 arranged to face each other with the outer cylinder member 2 interposed therebetween. Use of the halogen heater 11 facilitates local heating of the non-welding contact portion 46 of the outer cylinder member 2 described above. In addition, the arrival speed in the depth direction can be increased. For the example of the outer cylinder 1 with a needle described above, a preheating process in a short time of 100 W (12 V) × 2 seconds (S) is possible in order to heat to the heating range described above. In the preheating step, the periphery of the distal end joint portion 22 of the outer cylinder member 2 can be heated uniformly by rotating the needled outer cylinder 1 about its axis. In the present embodiment, the preheating process is performed for the non-welding contact portion 46, but the preheating process may be performed for other parts where cracks may occur. Moreover, you may perform a preheating process for the whole front-end | tip junction part 22. FIG.

Further, the heating means is not limited to the halogen heater 11 described above, and means such as a carbon heater or hot air may be used. For example, when the outer cylinder 1 with a needle is heated with hot air in a booth, for example, in the outer cylinder 1 with a needle having the same configuration as described above, the heating is performed at 290 ° C. × 6 seconds (S) in the booth. Heat to ℃ -150 ℃.

Next, the joining member welding step is performed after the above-described preheating step. As shown in FIG. 13, the joining member welding step is performed by pressing the joining member 4 with the outer member while pressing the distal end side tubular portion (leading end portion) 43 of the joining member 4 in the proximal direction of the joining member 4 by the pressing member 17. This is done by heat welding to the tip joint of the member 2. The pressing is preferably performed while pressing in the proximal direction of the joining member 4 with a pressure of 4N to 30N.

As described above, in the joining member 4 that is inserted into the distal end joining portion 22 of the outer tubular member 2 and in which the protruding portion 28 of the outer tubular member 2 and the abutting portion 48 of the joining member 4 are in contact, the outer tubular member 2 The taper-shaped lumen 26 and the bonding outer peripheral portion (tapered portion) 47 of the bonding member 4 are in a taper-fitted state or a state close to a taper-fitting. In this state, heat welding is performed.

The pressing member 17 includes a receiving hole 19 that stores the needle tube 3 and a pressing portion 18 that presses the distal end side tubular portion 43 of the joining member 4. When pressure is applied to the joining member 4 by the pressing portion 18, the protruding portion 28 of the outer cylinder member 2 and the abutting portion 48 of the joining member 4 are in contact with each other. Also transmitted to the part. And the state of the outer peripheral surface of the joining outer peripheral part 47 and the taper-shaped lumen | bore 26 can be maintained in a joining member welding process. Then, the joining member 4 is securely bonded to the outer cylinder member by heating and partial melting of the joining member 4. In particular, in this embodiment, the joint outer peripheral portion 47 of the joining member 4 and the inner cavity 26 of the outer cylindrical member 2 are both tapered, so that a force compressing in the axial direction acts on the resin melted during heating. Therefore, heat welding can be reliably performed.

In the present embodiment, heat welding is generated using the semiconductor laser irradiation apparatus 20. The semiconductor laser irradiation apparatus 20 irradiates a laser on the heat welding portion 45 between the bonding outer peripheral portion 47 of the bonding member 4 and the tapered lumen 26 of the outer cylindrical member 2. Thereby, the needle tube 3 generates heat and the joining member 4 is heated. Then, the joining member 4 softens and adheres to the needle tube 3 and the tip joining portion 22 of the outer cylinder member 2. As a result, the joining member 4 and the needle tube 3, and the joining part 4 and the tip joining part 22 of the outer cylinder member 2 are fixedly joined by heat welding, and the outer cylinder 1 with a needle is manufactured.

The proximal end side cylinder portion 41 of the joining member 4 is not softened and deformed to an outer diameter larger than the inner diameter of the opening of the tapered lumen 26, so that the pressing member 17 and the joining outer peripheral portion 47 are connected. In order to allow the surfaces of the tapered lumens 26 to be brought into close contact with each other, the irradiation range of the semiconductor laser irradiation apparatus is determined so that only a predetermined range of the heat welding portion 45 near the proximal end of the joining member 4 is melted. . At this time, the laser beam is applied to the thin portion between the ribs of the taper fitting portion 24.

Moreover, the heat welding part 45 can be set to an arbitrary position, and thereby the flexibility (deflection) of the needle tube can be controlled. For example, in order to prevent the occurrence of kink (breaking) by making the needle tube easy to bend, the heat welded portion 45 is moved from the middle of the taper fitting portion 24 to the vicinity of the proximal end or from the middle of the joining member 4 to the vicinity of the proximal end. It is preferable to provide the heat welding portion 45 from the vicinity of the middle of the taper fitting portion 24 to the vicinity of the tip or from the vicinity of the middle of the bonding member 4 to the vicinity of the tip when bending is not desired.

When the thickness of the joining member 4 is 0.38 to 0.48 mm and the thickness of the portion without the rib of the tapered fitting portion 24 of the outer cylinder is 0.8 to 1.1 mm, the semiconductor laser irradiation device 20 The output is preferably set to 5 to 20 W, and the laser irradiation time is preferably set to 1.5 to 2.0 seconds (S). For the optical system, it is preferable to set the focal diameter to φ3.0 to 3.5 mm. The above conditions are for the case where cyclic polyolefin (COP) is applied as the material of the joining member, but the resin temperature is set to an appropriate value in accordance with the characteristics of the resin used so that foaming, resin burning and deformation do not occur. It is necessary to set such conditions. In the present embodiment, since the joining member 4 and the needle tube 3 and the joining member 4 and the outer cylinder member 2 are joined using the semiconductor laser irradiation device 20, the needle tube 3 is attached to the outer cylinder member 2 without using an adhesive. Can be fixed.

Further, not only the semiconductor laser irradiation apparatus 20 in the joining member welding process of the above-described embodiment, but other welding means may be used. For example, as in another embodiment shown in FIG. 14, high-frequency induction heating device 16 may be used to cause thermal welding. The high-frequency induction heating device 16 includes a work coil 15 and a power source 16 a that causes an alternating current to flow through the work coil 15. When an alternating current is passed from the power supply 16 a to the work coil 15, a magnetic field is generated around the work coil 15, and an eddy current is generated in the needle tube 3. Thereby, the needle tube 3 generates heat and the joining member 4 is heated. Then, the joining member 4 softens and adheres to the needle tube 3 and the tip joining portion 22 of the outer cylinder member 2. As a result, the joining member 4 and the needle tube 3, and the joining part 4 and the tip joining part 22 of the outer cylinder member 2 are fixedly joined by heat welding, and the outer cylinder 1 with a needle is manufactured.

In the above-described embodiment, the outer cylinder member 2 and the joining member 4 are made of substantially the same material. If they are substantially the same material, they have good compatibility. In addition, it is good also as making the material of the outer cylinder member 2 and the joining member 4 into a different thermoplastic resin which has compatibility at the time of a fusion | melting. Having compatibility indicates that the thermodynamic mutual solubility is good, in other words, indicates that no separation occurs between the two after curing.

In the above-described embodiment, the outer cylinder member of the needle-equipped outer cylinder is a syringe outer cylinder member that can be filled with a chemical solution. The outer cylinder member of the needle-equipped outer cylinder may be a needle hub member that can be attached to a nozzle portion provided at the distal end of a syringe outer cylinder that can be filled with a chemical solution. In this case, the needle hub member has a mounting portion that can be mounted on the nozzle portion of the syringe outer cylinder at the base end portion. An outer cylinder with a needle using such a needle hub member can also be used to puncture the needle tip of the needle tube from the surface of the skin and inject a drug solution filled in the syringe outer cylinder into the living body.

Moreover, the outer cylinder with a needle of the present invention may be manufactured by using a needle tube and a joining member which are integrally formed in advance by insert molding. Even in this case, in the joining member welding step, the joining outer peripheral portion of the joining member is melted and solidified at a position that is a predetermined long base end side from the tip of the tip joining portion of the outer cylinder member, whereby a heat welding portion is formed. . The joining member is fixedly joined to the inner peripheral surface of the distal end joining portion of the outer cylinder member by the outer peripheral portion of the thermal welding portion, and is firmly joined to the outer peripheral surface of the needle tube by the inner peripheral portion of the thermal welding portion. In this case, the joining member is not attached to the part other than the heat-welded part of the joined outer peripheral part.

The needled outer cylinder of the present invention is as follows.
(1) A joining member having a needle tube, a needle tube housing hole for housing a proximal end portion of the needle tube, and a joining outer peripheral portion provided at an outer periphery of the needle tube housing hole, and the joining of the joining member from a distal end side An outer cylinder with a needle comprising an outer cylinder member having a tip joint portion having a lumen capable of receiving an outer peripheral portion,
The needle tube storage hole passes through the joining member from the distal end of the joining member to the proximal end of the joining member,
The outer cylinder member is provided at a proximal end portion of the lumen and includes a protruding portion projecting into the lumen, and the joining member projects at the proximal end portion of the joining member. An abutting portion that abuts on a portion, at least the joining outer peripheral portion of the joining member is inserted into the lumen of the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is Abutting against the protrusion of the outer cylinder member;
The joining outer peripheral portion of the joining member has a heat-welded portion formed at a position that is a predetermined long base end side from the distal end of the distal joint portion of the outer cylinder member, and the joining outer peripheral portion of the joining member is An outer cylinder with a needle fixedly bonded to the inner peripheral surface of the tip bonded portion at the outer peripheral portion of the heat welded portion and fixedly bonded to the outer peripheral surface of the needle tube at the inner peripheral portion of the heat welded portion.

In this outer cylinder with a needle, the bonding member is well fixedly bonded to the outer cylinder member and can be used effectively.

Further, the above embodiment may be as follows.
(2) The outer cylinder with a needle according to (1), wherein the contact portion of the joining member is configured by a rib formed in a proximal direction of the joining member and extending in a proximal direction.
(3) The needled outer cylinder according to (1), wherein the contact portion of the joining member is configured by a proximal end surface of the joining member.
(4) The needle according to any one of (1) to (3), wherein the joining member includes a needle tube locking portion that is provided at a proximal end portion of the needle tube storage hole and locks the proximal end of the needle tube. With outer cylinder.
(5) The needle according to any one of (1) to (3), wherein the outer cylinder member includes a needle tube locking portion that is provided at a proximal end portion of the lumen and locks the proximal end of the needle tube. With outer cylinder.
(6) The joining outer peripheral portion of the joining member is a tapered portion having an outer diameter reduced from the distal end to the base end of the joining outer peripheral portion, and the lumen of the outer tubular member is the outer cylinder. The needled outer cylinder according to any one of the above (1) to (5), which is a tapered lumen having a diameter reduced toward the base end of the member.
(7) The front end joining portion of the outer cylinder is not welded to the joining member and is in non-welding contact with the joining member at a position closer to the front end side than the heat welding portion of the joining member. The outer cylinder with a needle according to any one of the above (1) to (6), which has a contact portion, and the non-welding contact portion has a residual strain and does not have a crack.
(8) The outer cylinder with a needle according to any one of (1) to (7), wherein the forming material of the joining member and the forming material of the outer cylinder member are thermoplastic resins having compatibility when melted.
(9) The outer cylinder with a needle according to any one of the above (1) to (8), wherein the outer cylinder member is a syringe outer cylinder member having an outer cylinder main body that can be filled with a chemical solution.
(10) With the needle according to any one of (1) to (8), the outer cylinder member is a needle hub member having a mounting portion that can be mounted on a nozzle portion provided at a distal end portion of a syringe outer cylinder. Outer cylinder.

The prefilled syringe of the present invention is as follows.
(11) The outer cylinder with a needle according to the above (9), the chemical solution filled in the inside of the outer cylinder main body, and housed in the outer cylinder main body and sliding in the outer cylinder main body A prefilled syringe comprising a possible gasket and a cap attached to the tip of the outer cylinder with a needle and sealing the needle tip of the needle tube.

Also in this prefilled syringe, the joining member is well fixedly joined to the outer cylinder member and can be used effectively.

The manufacturing method of the outer cylinder with a needle | hook of this invention is as follows.
(12) A joining member having a needle tube, a needle tube storage hole into which the needle tube is inserted, and a joint outer peripheral portion provided on an outer peripheral portion of the needle tube storage hole, and an inner portion capable of receiving the joint outer peripheral portion of the joint member A method of manufacturing an outer cylinder with a needle comprising an outer cylinder member having a distal end joint having a cavity,
The outer cylinder member provided with a protruding portion protruding into the lumen at a proximal end portion of the lumen, and the joining member provided with a contact portion contacting the protruding portion of the outer cylinder member at a proximal end portion; A preparation step of preparing the needle tube;
The needle tube is inserted into or inserted into the needle tube housing hole of the joining member, the joining member is inserted into the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is the outer cylinder member An assembly step of assembling the needle tube, the joining member, and the outer cylinder member so as to abut against the protruding portion of
While the distal end portion of the joining member is pressed in the proximal direction of the joining member by the pressing member, the needle tube is heated by a heating device that heats the needle tube, whereby the joining outer peripheral portion of the joining member is moved to the outer cylinder. A method of manufacturing an outer cylinder with a needle, comprising: a welding step of thermally welding the inner peripheral surface of the tip joint portion of the member and the outer peripheral surface of the needle tube.

In this manufacturing method, the lower end of the joining member is in contact with the protruding portion provided at the proximal end portion of the lumen of the outer cylinder member, and the distal end portion of the joining member is fixed to the base of the joining member by the pressing member. Since the joining member is thermally welded to the tip joining portion of the outer cylinder member while pressing in the end direction, sufficient pressure can be applied to the molten resin, and the joining member is firmly fixed and joined to the outer cylinder member. The

Further, the above embodiment may be as follows.
(13) The joining member is provided at a proximal end portion of the needle tube storage hole, and includes a needle tube locking portion that locks the proximal end of the needle tube. In the assembly step, the joining member is provided in the needle tube storage hole. The manufacturing method of the outer cylinder with a needle according to (12), wherein the proximal end of the inserted needle tube is locked by the needle tube locking portion.
(14) The method for manufacturing the outer cylinder with a needle according to the above (12) or (13), wherein the forming material of the joining member and the forming material of the outer cylinder member are thermoplastic resins having compatibility when melted.

Claims

A joining member having a needle tube, a needle tube housing hole for housing a proximal end portion of the needle tube, and a joining outer peripheral portion provided on an outer peripheral portion of the needle tube housing hole; and the joining outer peripheral portion of the joining member from the distal end side. An outer cylinder with a needle comprising an outer cylinder member having a distal end joint having a receivable lumen,
The needle tube storage hole passes through the joining member from the distal end of the joining member to the proximal end of the joining member,
The outer cylinder member is provided at a proximal end portion of the lumen and includes a protruding portion projecting into the lumen, and the joining member projects at the proximal end portion of the joining member. An abutting portion that abuts on a portion, at least the joining outer peripheral portion of the joining member is inserted into the lumen of the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is Abutting against the protrusion of the outer cylinder member;
The joining outer peripheral portion of the joining member has a heat-welded portion formed at a position that is a predetermined long base end side from the distal end of the distal joint portion of the outer cylinder member, and the joining outer peripheral portion of the joining member is With a needle characterized by being fixedly bonded to the inner peripheral surface of the tip bonded portion at the outer peripheral portion of the heat welded portion and fixedly bonded to the outer peripheral surface of the needle tube at the inner peripheral portion of the heat welded portion. Outer cylinder.
2. The outer cylinder with a needle according to claim 1, wherein the abutting portion of the joining member is configured by a rib formed in a proximal end direction formed at a proximal end of the joining member.
The outer cylinder with a needle according to claim 1, wherein the contact portion of the joining member is configured by a proximal end surface of the joining member.
4. The outer cylinder with a needle according to claim 1, wherein the joining member includes a needle tube locking portion that is provided at a proximal end portion of the needle tube storage hole and locks the proximal end of the needle tube.
4. The outer cylinder with a needle according to claim 1, wherein the outer cylinder member includes a needle tube locking portion that is provided at a proximal end portion of the lumen and that locks the proximal end of the needle tube.
The joining outer peripheral portion of the joining member is a tapered portion whose outer diameter is reduced from the distal end to the base end of the joining outer peripheral portion, and the lumen of the outer tubular member is a base of the outer tubular member. The outer cylinder with a needle according to any one of claims 1 to 5, wherein the outer cylinder is a tapered lumen having a diameter reduced toward an end.
The non-welding contact portion that is not thermally welded to the joining member and is in contact with the joining member is provided at the tip joining portion of the outer cylinder at a portion closer to the distal end side than the thermal welding portion of the joining member. The outer cylinder with a needle according to claim 1, wherein the non-welding contact portion has a residual strain and does not have a crack.
The outer cylinder with a needle according to any one of claims 1 to 7, wherein the forming material of the joining member and the forming material of the outer cylinder member are thermoplastic resins having compatibility when melted.
The outer cylinder with a needle according to any one of claims 1 to 8, wherein the outer cylinder member is a syringe outer cylinder member having an outer cylinder main body that can be filled with a chemical solution.
9. The outer cylinder with a needle according to claim 1, wherein the outer cylinder member is a needle hub member having a mounting portion that can be mounted on a nozzle portion provided at a distal end portion of a syringe outer cylinder.
The outer cylinder with a needle according to claim 9, the chemical liquid filled in the inside of the outer cylinder main body, a gasket that is housed in the outer cylinder main body and that can slide in the outer cylinder main body, A prefilled syringe comprising a cap attached to a distal end portion of the outer cylinder with the needle and sealing the needle tip of the needle tube.
A joint member having a needle tube, a needle tube storage hole into which the needle tube is inserted, and a joint outer peripheral portion provided in an outer peripheral portion of the needle tube storage hole; and a lumen capable of receiving the joint outer peripheral portion of the joint member A method for manufacturing an outer cylinder with a needle comprising an outer cylinder member provided with a tip joint portion,
The outer cylinder member provided with a protruding portion protruding into the lumen at a proximal end portion of the lumen, and the joining member provided with a contact portion contacting the protruding portion of the outer cylinder member at a proximal end portion; A preparation step of preparing the needle tube;
The needle tube is inserted into or inserted into the needle tube housing hole of the joining member, the joining member is inserted into the tip joining portion of the outer cylinder member, and the abutting portion of the joining member is the outer cylinder member An assembly step of assembling the needle tube, the joining member, and the outer cylinder member so as to abut against the protruding portion of
While the distal end portion of the joining member is pressed in the proximal direction of the joining member by the pressing member, the needle tube is heated by a heating device that heats the needle tube, whereby the joining outer peripheral portion of the joining member is moved to the outer cylinder. A method for manufacturing an outer cylinder with a needle, comprising: a welding step of thermally welding the inner peripheral surface of the tip joint portion of the member and the outer peripheral surface of the needle tube.
The joining member is provided at a proximal end portion of the needle tube storage hole, includes a needle tube locking portion that locks the proximal end of the needle tube, and is inserted into the needle tube storage hole of the joining member in the assembly step. The manufacturing method of the outer cylinder with a needle | hook of Claim 12 which latches the base end of a needle tube with the said needle tube latching | locking part.
The method for manufacturing an outer cylinder with a needle according to claim 12 or 13, wherein the forming material of the joining member and the forming material of the outer cylinder member are thermoplastic resins having compatibility when melted.